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Clinical Trials/NCT06578312
NCT06578312
Completed
N/A

A Study on Establishing a "Critical State" Early Warning Score After Congenital Heart Disease Surgery and an Integrated Treatment Model of a Multidisciplinary Rapid Response Team

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country4,115 target enrollmentJanuary 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
4115
Locations
1
Primary Endpoint
event occurrence-an inclusion of composite clinical diagnose
Status
Completed
Last Updated
last year

Overview

Brief Summary

By establishing a warning scoring tool for the early "critical state" after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

Detailed Description

All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
July 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xu Wang

Chief Physician

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

  • pediatrics admitted to ICU

Exclusion Criteria

  • surgery without cardiopulmonary bypass
  • using extra-corporeal circulation during surgery
  • Delayed chest closing during surgery

Outcomes

Primary Outcomes

event occurrence-an inclusion of composite clinical diagnose

Time Frame: Within 48 hours after surgery

critical status included clinical diagnose:arrhythmia(ventricular tachycardia、ventricular fibrillation、refractory supraventricular tachycardia ),prognosis(death or live),bedside thoracotomy,CPR,ECMO,extracorporeal circulation establishment,renal replacement therapy,peritoneal dialysis, hemofiltration. If one of the above diagnosis and treatment used in patients, they would be divided to case group.

Study Sites (1)

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